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Bloomberg - Absence of Evidence in Medicare Genetic Test Decision

April 4, 2018

Author:

Greg Langlois

The Medicare program’s decision to cover personalized medicine tests for cancer patients earned praise from industry groups and others, but one cancer research advocacy group told me the government insurer could have done more to help researchers understand how well the tests work.

The Centers for Medicare & Medicaid Services said March 16 it would reimburse the costs of next-generation sequencing (NGS) diagnostic tests if they are FDA-approved companion diagnostics. Right now, a Cambridge, Mass.-based Foundation Medicine Inc. product is the only one that meets the new coverage criteria.

The CMS opted not to include coverage with evidence development, which would have required providers of not-yet-approved NGS tests to collect data on how well they’re working in exchange for Medicare paying for them.

“The goal of that would be that if they, in the long run, show through this collection process that the utilization of their test is improving the longer-term health benefits of the population that the test is being used for, then they may be eligible for full reimbursement,” Friends of Cancer Research Chief Executive Officer Jeff Allen explained to me an interview. “And while they’re developing it, the test will be paid for as well.”

Including coverage with evidence development “could have set a standard for labs to be able to demonstrate more broadly their analytical and clinical validity and the performance of their tests,” Allen said. “And it would have been an opportunity to try and help standardize different tests with their same intended use.”

The CMS originally included coverage with evidence development in its preliminary NGS coverage determination, but removed it after receiving comments from the public.

“Many commenters reported that they are already developing or have developed the evidence to demonstrate these diagnostic laboratory tests using NGS to improve health outcomes for Medicare beneficiaries with cancer—or are equipped to conduct their own studies to generate evidence that use of the test guides management and treatment, and improves health outcomes for the Medicare population,” the CMS said in a statement announcing its decision.